# K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 3, 2016 after 30 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002400 (2000). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073377: Acl Top (with System Software V3.0.0), Instrumentation Laboratory CO (2008) Summary page 4.
- K091980: Acl Top 700 Las, Instrumentation Laboratory CO (2009) Summary page 4.

## Most influential descendants
- K183390: QNext and DG-PT (2019), 0 descendants of its own
- K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (2018), 0 descendants of its own

## Recalls of this device
- Feb 22, 2022 · Class II · Z-1014-2022: Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa r

## Indications for use
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

Source page: https://510kreport.com/device/K160276
Methodology: https://510kreport.com/methodology